Prostatic Neoplasm
Conditions
Keywords
prostate cancer;, biochemical recurrence;, salvage radiotherapy;, SBRT;
Brief summary
After radical prostatectomy, 30-60% of patients will develop recurrent disease. Salvage radiotherapy, usually at 2 Gy per fraction, is the main treatment option for these patients. The aim of the present study is to determine the 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after radical prostatectomy.
Detailed description
The present study aims at delivering 30 Gy to the prostatic bed in 5 fractions. At the same time, the pelvic nodes will be covered to 25 Gy, but in those patients considered at low risk of nodal involvement. In patients with evidence of macroscopic disease at the tumor bed through DCE-MRI, 40 Gy will be delivered in 5 fractions. Selected patients will receive 6-month LHRH analogue preceded by Bicalutamide tablet 50 mg, daily, for 2 weeks to control for possible tumor flare.
Interventions
RADIATIONsalvage SBRT
steretactic body radiation therapy in the setting of salvage radiotherapy for prostate cancer
Sponsors
Alessia Farneti
Adriana Faiella
Marta Bottero
Pasqualina D'Urso
Valeria Landoni
Antonella Soriani
Luca Bertini
Regina Elena Cancer Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* \- Able and willing to provide informed consent; * Pathologically proven diagnosis of prostatic adenocarcinoma; * Biochemical failure (2 consecutive PSA rises above 0.2 ng/ml) after radical prostatectomy; * No regional or distant metastases; * Eastern Cooperative Oncology Group performance status 0-1
Exclusion criteria
* \- Previous local treatment of the prostate with radiotherapy, brachytherapy, cryosurgery, high-intensity focused ultrasound or cryotherapy; * Previous radiotherapy to the pelvis; * Previous or current symptomatic vesicourethral anastomotic stenosis post-RP (weak stream, straining to void, hesitancy and incomplete bladder emptying); * PSA level at sRT\> 2 ng/ml; * (Each single) Lesion volume within the prostatic fossa at mpMR \>5 cc; * Previous chemotherapy for malignancy in past 5 years; * Previous androgen deprivation for biochemical failure after RP; * Contraindication to short term AD (in case of Px) * Presence of nodal or distant metastasis, as confirmed by magnetic resonance (MR) or PET/CT * Pathologically positive lymph nodes (pN+) at RP; * Serious medical comorbidities or other contraindications to radiotherapy * Presence of active inflammatory bowel disease; * Presence of active connective tissue disease; * Unable or unwilling to complete quality of life questionnaires
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3-yr BFFS | 3-years | The primary objective of the study is 3-yr biochemical failure free survival of the stereotactic approach in 5 fractions in the context of salvage radiotherapy for biochemical failure after RP |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 3-y LC | 3-years | The secondary objective is 3-yr locoregional control assessed with PSA |
| 3-y MFS | 3-years | The secondary objective is 3-yr metastases free survival |
| 3-y OS | 3-years | The secondary objective is 3-yr overal survival |
| 3-y QoL | 3-years | The secondary objective is 3-yr quality of life (FACT-P, IIF-5, ICIQ-SF, IPSS, IBQD) |
| 3-y - Patient satisfaction with treatment | 3-years | The secondary objective is 3-y patient satisfaction with treatment (FACIT-TS-G) |
| 3-y GU GI tox | 3-years | The secondary objective is 3-yr genitourinary and gastrointestinal toxicity according to CTCAE v5.0 |
Countries
Italy
Contacts
Primary ContactGiuseppe Sanguineti, Professor
Backup ContactPaola Franzoso, DM
Outcome results
None listed